Pre-Conference Workshop: International Regulatory Collaborative Initiatives: Reliance, Work-Sharing - Strategic Regulatory Pathways

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Description International regulatory collaboration is transforming how pharmaceutical companies navigate regulatory approval pathways. This full-day workshop explores the evolving landscape of reliance and work-sharing initiatives, providing industry professionals with practical insights and strategies to optimize regulatory planning across multiple jurisdictions.

Attendees will gain comprehensive understanding of various collaborative frameworks-including the ACCESS Consortium (Australia-Canada-Singapore-Switzerland-United Kingdom), EMA reliance activities, and the metrics of such mechanisms-and how these initiatives enable more efficient regulatory pathways while respecting national regulatory autonomy.

Through break-out sessions with case studies and expert perspectives from both industry and regulatory authorities (EMA International, MHRA International and/or Swissmedic) attendees will learn how international collaboration can lead to:

- Acceleration of product approvals across multiple markets

- Reduction of duplicative regulatory efforts and resource burden

- Enhancement of regulatory predictability and strategic planning

- Easier navigation of the complexities of multi-jurisdictional submissions

The workshop will examine key metrics from different collaborative procedures, providing insights into their effectiveness and practical application. Interactive breakout sessions will allow attendees to engage deeply with specific topics and share experiences with peers and experts.

Attendees will leave equipped with actionable strategies to incorporate reliance and work-sharing pathways into their global development plans, submission strategies, and portfolio management-strengthening their strategic impact within their organizations and across the global regulatory ecosystem.

Who Should Attend

This workshop is designed for:

- Regulatory affairs professionals managing global submissions and strategies

- Portfolio and project managers overseeing multi-jurisdictional development programs

- Senior regulatory strategists seeking to optimize global regulatory pathways

- Anyone involved in international regulatory planning and stakeholder engagement